Balloon folding apparatus, methods and products

ABSTRACT

A medical balloon may be configured by at least partially inflating the medical balloon and forming at least one primary lobe in the balloon. The primary lobe extends from a central portion of the balloon. The primary lobe may be manipulated to form at least two secondary lobes therefrom. The balloon may then be deflated and the secondary lobes wrapped around the balloon.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/087303, filed on Feb. 28, 2002, the contents of which are herebyincorporated by reference.

BACKGROUND OF THE INVENTION

Medical balloons are used in the body in a variety of applicationsincluding as dilatation devices for compressing plaque and for expandingprosthetic devices such as stents at a desired location in a bodilyvessel. Because it is typically necessary for the balloon to traverse atortuous anatomy as it is being delivered to the location in a bodilyvessel, it is desirable for the balloon to assume as low a profile aspossible.

One way to achieve a low profile is by folding the balloon to form anumber of wings. Current technologies typically employ a number of harddies, which are moved radially inward toward the center of a partiallyinflated balloon. The balloon is maintained in a partially inflatedstate until the dies have reached the end of their stroke. A vacuum isthen applied to the balloon to deflate the balloon and form wings thatconform to the configuration of the dies. The wings may then be wrappedor rolled around the circumference of the balloon. This method is noteffective, however, for forming wings with undercuts or multiple layers.

Where a balloon with wrapped wings is used to expand a stent, arotational moment is imparted on the stent as a result of the unfoldingof the wings as the balloon expands. The interaction between the stentand the balloon may cause undesirable wear to the stent and/or balloon.Where the stent comprises a coating, the rotational movement may damagethe coating and may damage the wall of the vessel in which the stent islocated.

Balloons with rolled wings also exhibit non-circular, irregularcross-sections. The irregular cross-section can facilitate contactbetween adjacent struts of a crimped-on stent. This contact can, inturn, lead to bonding between adjacent struts on coated stents when thestent is sterilized and the coating softens.

There remains a need for innovative methods for folding balloons, whichavoid some of the problems that may result, in certain circumstances,from balloons having rolled wings. There also remains a need forinnovative methods for folding balloons, in particular where multi-layerfolds are desired.

All US patents and applications and all other published documentsmentioned anywhere in this application are incorporated herein byreference in their entirety. Without limiting the scope of the inventiona brief summary of the claimed embodiments of the invention is set forthbelow. Additional details of the summarized embodiments of the inventionand/or additional embodiments of the invention may be found in theDetailed Description of the Invention below.

A brief abstract of the technical disclosure in the specification isprovided as well for the purposes of complying with 37 C.F.R. 1.72.

SUMMARY OF THE INVENTION

In one embodiment, the invention is directed to a method of configuringmedical balloon catheter assembly comprising the steps of providing amedical balloon, at least partially inflating the medical balloon,forming a plurality of primary lobes extending from a central portion ofthe balloon and spaced about the periphery of the balloon andmanipulating at least one primary lobe to form at least two secondarylobes therefrom. Finally, the balloon is deflated.

The primary lobes may be formed by applying a radially inward force tothe balloon at one or more locations. A plurality of first impingingmembers spaced about the periphery of the balloon may be directedradially inward to apply the radially inward force to the balloon.

Some or all of the primary lobes may be manipulated so as to form atleast two adjacent secondary lobes from each primary lobe that has beenmanipulated. Desirably, a radially inward force is applied to eachprimary lobe during the manipulating step to form a pair of secondarylobes from each primary lobe. A plurality of second impinging membersspaced about the periphery of the balloon may be directed radiallyinward to apply the radially inward force to the primary lobes and formthe secondary lobes. Some or all of the primary lobes may also bemanipulated to form at least three secondary lobes. This may beaccomplished by a variety of methods including by impinging two or moresecond impinging members inward against each primary lobe. In oneembodiment of the invention, a first secondary lobe, a second secondarylobe and a third secondary lobe are formed from each primary lobe. Thefirst secondary lobe is larger than the second secondary lobe and thethird secondary lobe.

The inventive method may further comprise the step of applying a vacuumto the balloon following formation of the secondary lobes to deflate theballoon. Optionally, depending on how many secondary lobes are formedfrom each primary lobe during the deflating step, a plurality ofantenna-shaped structures extending from a central portion of theballoon may be formed. Each antenna-shaped structure includes a centerantenna portion extending outward from the balloon and a plurality ofwings extending from a first side of the center antenna portion and aplurality of wings extending from a second side of the center antennaportion opposite the first side. In one embodiment, the antenna-shapedstructure includes two wings extending from the first side of thecentral portion of the balloon and two wings extending from the secondside of the central portion of the balloon.

The inventive method may optionally comprise the further step ofwrapping the deflated secondary lobes about the central portion of theballoon. Desirably, secondary lobes that are formed from the sameprimary lobe are wrapped in opposite directions from one another aboutthe central portion of the balloon. This may be accomplished, forexample, by wrapping every other secondary lobe in a first directionabout the central portion of the balloon and subsequently wrapping anyunwrapped lobes in a second direction opposite the first direction aboutthe central portion of the balloon.

Upon completion of the wrapping of the balloon, desirably each pair ofsecondary lobes includes a first secondary lobe, which overlaps, withone secondary lobe from an adjacent pair of secondary lobes and a secondsecondary lobe, which is overlapped by one secondary lobe from anotheradjacent pair of secondary lobes.

The wrapping of the balloon may be accomplished through a variety ofmethods including by using a plurality of third impinging members toapply a force to every other secondary lobe. Desirably, the force willbe directed toward the central portion of the balloon. A plurality offourth impinging members may then be used to apply a force to everyremaining unwrapped lobe to wrap the remaining lobes. Desirably, theforce will be directed toward the central portion of the balloon.

In another embodiment, the invention is also directed to a method offorming balloon wings in a medical balloon comprising the steps ofproviding a medical balloon with one or more primary lobes therein,forming a plurality of secondary lobes from each primary lobe byapplying an inward force to each of the primary lobes and deflating theballoon. Desirably, the inward force is applied to the primary lobes viaa plurality of impinging members. The impinging members may be removedfollowing the forming step by optionally moving the impinging members inan axial direction.

In another embodiment, the invention is also directed to the combinationof a medical balloon and an expandable prosthetic device disposed aboutthe medical balloon. The medical balloon comprises a plurality of wingsextending from a main balloon body, the wings wrapped about the mainballoon body such that upon inflation of the medical balloon there issubstantially no relative rotational movement between the prostheticdevice and the balloon.

In another embodiment, the invention is also directed to a medicalballoon having a central portion and a plurality of wings disposedthereabout, the plurality of wings including at least one first wingwrapped in a first direction about the central portion of the balloonand at least one second wing wrapped in a second direction opposite thefirst direction about the central portion of the balloon. Desirably, theballoon comprises a plurality of first wings wrapped in the firstdirection about the central portion of the balloon and a plurality ofsecond wings wrapped in the second direction about the central portionof the balloon. The first and second wings alternate with one anotherabout the central portion of the balloon.

In another embodiment, the invention is also directed to a medicalballoon comprising a central portion and a plurality of structuresextending from the central portion, each structure having a first wingextending therefrom in a first direction and a second wing extendingtherefrom in a second direction opposite the first direction. Typically,the structures are in the form of a T-shaped structure or a V-shapedstructure. Optionally, the structures may be spaced apart such that eachsecondary wing is in an overlapping relationship with one first wing.

In another embodiment, the invention is also to the combination of theinventive balloons disclosed herein and a prosthetic device, such as,for example, a stent disposed about the medical balloon. The prostheticdevice may include a coating comprising a therapeutic agent.

In another embodiment, the invention is also directed to the combinationof a medical balloon and an expandable prosthetic device disposed aboutthe medical balloon where the medical balloon comprising a plurality ofwings extending from a main balloon body. The wings are wrapped aboutthe main balloon body such that upon inflation of the medical balloonthere is substantially no relative rotational movement between theprosthetic device and the balloon.

The invention is also directed to an apparatus for configuring a medicalballoon of a medical balloon catheter assembly. The apparatus comprisesa catheter holder, a plurality of movable blades disposed about a commoncentral point and one or more blade moving devices in mechanicalcommunication with the movable blades, the one or more blade movingdevices is capable of moving the movable blades inward toward the commoncentral point.

Additional details and/or embodiments of the invention are discussedbelow.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 shows a longitudinal cross-section of a portion of a ballooncatheter assembly.

FIG. 2 is a transverse cross-section of a balloon catheter assembly withthe balloon at least partially inflated.

FIG. 3 is a transverse cross-section of a balloon catheter assembly withprimary lobes formed therein.

FIGS. 4-6 are transverse cross-sections of a balloon catheter assemblyduring the formation of secondary lobes.

FIG. 7 is a transverse cross-section of a V-formed balloon catheterassembly.

FIGS. 8-11 are transverse cross-sections of a balloon catheter assemblyillustrating the wrapping of the wings.

FIG. 12 is a transverse cross-section of a balloon with T-wings.

FIG. 13 shows an arrangement of a balloon and a plurality of impingingmembers prior to the formation of primary lobes.

FIG. 14 shows the balloon of FIG. 13 with primary lobes formed therein.

FIG. 15 is a transverse cross-section of a balloon catheter assemblythat has been manipulated to form three secondary lobes from everyprimary lobe.

FIG. 16 shows the balloon catheter assembly of FIG. 14 with thirdimpinging members applying a radially inward force to the some of thesecondary lobes.

FIG. 17 shows the balloon catheter assembly of FIG. 14 followingdeflation and the formation of antenna structures.

FIG. 18 shows the balloon catheter assembly of FIG. 17 with the antennastructures wrapped about the balloon.

FIG. 19 shows an inventive balloon with a stent disposed thereabout.

FIG. 20 shows the balloon and stent of FIG. 19 following expansion ofboth the balloon and stent.

FIG. 21 shows a top down perspective view of an inventive balloonconfiguring device.

FIG. 22 shows an alternate side perspective view of the inventiveballoon configuring device shown in FIG. 21.

FIG. 23 is an exploded perspective view of the front of the balloonconfiguring device shown in FIGS. 21 and 22.

FIG. 24 is an exploded view of the back of the inventive balloonconfiguring device shown in FIGS. 21-23.

FIGS. 25 and 26 show inventive impinging members which may be used inthe device of FIG. 21.

FIG. 27 shows a perspective view of an arrangement of impinging members.

FIG. 28 shows a side view of an arrangement of impinging members.

FIG. 29 shows a slidable impinging member.

DETAILED DESCRIPTION OF THE INVENTION

While this invention may be embodied in many different forms, there areshown in the drawings and described in detail herein specificembodiments of the invention. The present disclosure is anexemplification of the principles of the invention and is not intendedto limit the invention to the particular embodiments illustrated.

For the purposes of this disclosure, like reference numerals in thefigures shall refer to like features unless otherwise indicated.

In one embodiment, the invention is directed to a method of configuringa medical balloon catheter assembly such as that shown generally at 100in FIG. 1. Medical balloon catheter assembly comprises catheter tube 102and medical balloon 104 disposed thereabout. Inflation lumen 106 is influid communication with medical balloon 104. As shown in FIG. 1,inflation lumen 106 is disposed within catheter tube 102. The inflationlumen may also be provided in the form of a dual lumen tube, one lumenof which is in fluid communication with the balloon. Any other suitablearrangement may also be used for the inflation lumen.

In accordance with one embodiment of the invention, as shown in FIG. 2,medical balloon 104 is at least partially inflated and, optionally,fully inflated. At least one, and desirably, a plurality of firstimpinging members 108 are disposed about medical balloon 104. Typically,first impinging members 108 will have a relatively wide ballooncontacting surface. First impinging members 108 are directed inward toform a plurality of primary lobes 110 as shown in FIG. 3. Desirably,primary lobes 110 are spaced regularly about the periphery of theballoon and extend from central portion 112 of the balloon. In theembodiment of 2 and 3, a balloon with three primary lobes is shown byway of non-limiting example. Typically, the balloon will be manipulatedto have four, five, six, seven, eight, nine, ten or more primary lobes.More generally, the balloon may be manipulated to provide at least twoprimary lobes.

As shown in FIG. 4, at least one and desirably a plurality of secondimpinging members 114 are disposed against primary lobes 110, desirablyat the middle of the lobes. Typically, second impinging members 114 willhave a relatively narrow balloon contacting surface as compared withfirst impinging members 108. A radially inward force is applied to atleast one of the primary lobes by second impinging members 114 so as toform at least two secondary lobes 116 a and 116 b from the primary lobe110, as shown in FIG. 5.

Balloon 104 is then at least partially and desirably fully deflated byapplying a vacuum thereto to collapse inward and form collapsed lobes orwings 118 a and 118 b corresponding to secondary lobes 116 a and 116 bas shown in FIGS. 6 and 7.

The inventive V-formed balloon of FIGS. 6 and 7 may be wrapped in anumber of different ways. One method of wrapping the balloon is shown inFIGS. 8-11. As shown in FIG. 8, first impinging members 108 are removedfrom contact with the balloon. Second impinging members 114 may be leftin place or removed and replaced by other impinging members. A pluralityof third impinging members 120 are brought into contact with secondarywings 118 a and a plurality of fourth impinging members 122 are broughtinto contact with secondary wings 118 b.

Fourth impinging members 122 are moved inward relative to balloon 104 asshown in FIG. 10 and secondary wings 118 b are wrapped in a firstdirection about the central portion of the balloon. Third impingingmembers 120 are then moved inward relative to balloon 104 as shown inFIG. 11 and secondary wings 118 a are wrapped about the central portionof the balloon in a second direction opposite to the first direction. Bywrapping secondary wings 118 b separately from secondary wings 118 a,the possibility of the secondary wings 118 a and 118 b hitting oneanother during the wrapping steps is eliminated.

As shown in FIGS. 10 and 11, secondary wings 118 b are wrapped in acounter-clockwise direction first and secondary wings 118 a aresubsequently wrapped in a clockwise direction. It is also within thescope of the invention to first wrap secondary wings 118 a in aclockwise direction and to subsequently wrap secondary wings 118 b in acounter-clockwise direction.

The individual secondary wings 118 a may be wrapped simultaneously withone another or may be wrapped sequentially or in any other sequence.Similarly, individual secondary wings 118 b may be wrappedsimultaneously with one another or may be wrapped sequentially.

It is also within the scope of the invention to wrap one pair ofsecondary wings in first and second opposing directions and to wrap theother secondary wings in other ways.

Subsequent to wrapping the balloon, all of the impinging members may beremoved.

In accordance with the invention, as few as one pair of secondary wingsmay be formed and wrapped about the central portion of the balloon. Inthe embodiments shown in FIGS. 2-11, three pairs of secondary wings areformed and wrapped about the central portion of the balloon. Typically,two, three, four, five, six, seven, eight, nine, ten or more pairs ofsecondary wings will be formed and wrapped about the central portion ofthe balloon. More generally, a plurality of pairs of secondary wings maybe formed and wrapped.

The invention is also directed to a medical balloon such as that shownat 104 in FIG. 12 having a central portion 104 and a plurality of wingsdisposed thereabout including at least one first wing 118 a wrapped in afirst direction about the central portion of the balloon and at leastone second wing 118 b wrapped in a second direction opposite the firstdirection about the central portion of the balloon.

Desirably, as shown in FIG. 12, the balloon comprises a plurality offirst wings 118 a wrapped in the first direction and a plurality ofsecond wings 118 b wrapped in second first direction. In the embodimentof FIG. 12, the first and second wings alternate with one another aboutthe central portion of the balloon. The first and second wings form partof a T-shaped structure, shown generally at 124 with hatching, extendingfrom the central portion of the balloon. Each T-shaped structureincludes one first wing and one second wing. Desirably, as shown in FIG.12, each secondary wing 118 b is in an overlapping relationship with onefirst wing 118 a.

The invention is also directed to a medical balloon having a centralportion and a plurality of T structures and/or V structures extendingfrom the central portion, the structure having a first wing extendingtherefrom in a first direction and a second wing extending therefrom ina second direction opposite the first direction. Desirably, as shown inFIG. 12, the balloon comprises a plurality of T-shaped structures 124extending from central portion 112 of balloon 104.

The invention is further directed to a method of configuring a medicalballoon in which multiple secondary lobes are formed from primary lobesusing impinging members that apply a non-radially inward force to theprimary lobes.

As shown in FIGS. 13 and 14, one or more pairs of impinging members 114are disposed about the periphery of balloon 104. One or more primarylobes 110 are formed by moving impinging members 114 substantiallyradially inward. Impinging members 114 are then repositioned or newimpinging members are provided, as shown in FIG. 15, on either side ofprimary lobe 110 and an inward force applied against primary lobe 110 toform three secondary lobes 116 a-c. Desirably, each primary lobe is thustransformed into three secondary lobes. Optionally, as shown in FIG. 15,first secondary lobe 116 b is larger than second secondary lobe 116 aand third secondary lobe 116 c. The first, second and third secondarylobes may also be of the same size as one another. Other sizerelationships between the first, second and third secondary lobes arealso within the scope of the invention.

Desirably, impinging members 114 shown in FIGS. 15, 25 and 26 compriseelongate structures such as wires that are held in tension or plasticparisons. The elongate structures may be disposed parallel to thelongitudinal axis of the balloon. The required number of elongatestructures will depend on how many secondary lobes are to be formed fromeach primary lobe. Generally, where it is desired to form N lobes from aprimary lobe, N-1 elongate structures will be required. The impingingmembers may also be in the form of bar, rods or any other structure thatmay be used to apply a force to the balloon without damaging theballoon. Suitably, the impinging members will have a radiused portionthat contacts the balloon. The impinging members may be made of metal,polymeric material or any other suitable material. Desirably, secondimpinging members are removed subsequent to formation of the secondarylobes by moving the secondary impinging members in an axial direction.

The impinging members, when in the form of wires held in tension, maythen be removed by releasing one end and pulling or pushing the memberin an axial direction.

Balloon 104 may then be deflated, optionally by applying a vacuumthereto. During deflation, as shown in FIG. 16, a plurality of thirdimpinging members 120 may apply a radially inward force to secondarylobes 116 b. Typically, third impinging members 120 are in the form ofdies having curved faces that match the profile of the balloon. Upondeflation of balloon 104, as shown in FIG. 17, at least one anddesirably a plurality of antenna-shaped structures, shown generally at130, extend from a central portion 112 of the balloon. Desirably, eachantenna-shaped structure 130 includes a center antenna portion 130 aextending outward from the balloon and a plurality of wings 130 bextending from a first side of center antenna portion 130 a and aplurality of wings 130 c extending from a second side of center antennaportion 130 a opposite the first side. Further in accordance with theinvention, three or more wings may extend from each side of the centerantenna portion.

Antenna structures 130 may then be wrapped about the balloon by applyinga radially inward force to each antenna structure 130 using thirdimpinging members 120.

An inventive balloon with three antenna structures is shown in FIGS. 18and 19. Balloon 104 of FIG. 19 further comprises stent 135 having aplurality of struts 140 disposed thereabout. Upon expansion of balloon104 and stent 135, the stent remains in contact with the same points onthe balloon it was in contact with prior to expansion of the balloon andstent. As shown in FIGS. 19 and 20, stent 135 contacts balloon 104 atpoints of contact 137 a, 137 b and 137 c both prior to and followingexpansion of the balloon and stent.

The inventive methods disclosed herein may further comprise a heat-setstep to facilitate retention of the fold pattern produced by theprocess. Also, the inventive methods disclosed herein may optionallyfurther comprise the step of disposing a balloon protector about theballoon to assure that the balloon does not unwrap. An example of aballoon protector is disclosed in U.S. Pat. No. 5,893,868. The inventivemethods may further comprise one or more steps of coating the balloonwith a desired coating. Suitable coatings include retraction coatingssuch as those disclosed in U.S. Pat. No. 5,490,839, and U.S. Pat. No.5,738,901 and lubricity coatings such as those disclosed in U.S. Pat.No. 6,176,849.

Any of the inventive methods disclosed herein optionally may furthercomprise the step of disposing a prosthetic device about the medicalballoon. Desirably, the prosthetic device is a stent. More desirably,the stent includes a coating such as, for example, those coatingsdisclosed below.

The invention is also directed to medical balloons formed by using anyof the inventive balloon configuring methods disclosed herein as well asto the balloons described herein in their various configurations.

An inventive apparatus suitable for preparing some of the inventivemedical balloons described herein is disclosed below.

In another embodiment, the invention is also directed to the combinationof a medical balloon and an expandable prosthetic device disposed aboutthe medical balloon where the medical balloon comprising a plurality ofwings extending from a main balloon body. The wings are wrapped aboutthe main balloon body such that upon inflation of the medical balloonthere is substantially no relative rotational movement between theprosthetic device and the balloon. An example of such a combination isshown at 150 in FIG. 19.

The inventive balloon disclosed herein, in many of its embodiments, hasa profile that is closer to circular than existing wrapped balloons.This feature results in less damage to the balloon during crimping of astent disposed thereabout.

The invention is further directed to the combination of an inventivemedical balloon such as those disclosed herein and a prosthesis, suchas, for example, a stent, with the prosthesis disposed about the medicalballoon. Desirably, the prosthesis includes a coating, desirablycomprising a therapeutic agent. The term therapeutic agent is intendedto include drugs, non-genetic therapeutic agents, genetic materials,cells.

Suitable coatings include polymer coating materials such aspolycarboxylic acids, cellulosic polymers, including cellulose acetateand cellulose nitrate, gelatin, polyvinylpyrrolidone, cross-linkedpolyvinylpyrrolidone, polyanhydrides including maleic anhydridepolymers, polyamides, polyvinyl alcohols, copolymers of vinyl monomerssuch as EVA, polyvinyl ethers, polyvinyl aromatics, polyethylene oxides,glycosaminoglycans, polysaccharides, polyesters including polyethyleneterephthalate, polyacrylamides, polyethers, polyether sulfone,polycarbonate, polyalkylenes including polypropylene, polyethylene andhigh molecular weight polyethylene, halogenated polyalkylenes includingpolytetrafluoroethylene, polyurethanes, polyorthoesters, proteins,polypeptides, silicones, siloxane polymers, polylactic acid,polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate andblends and copolymers thereof, coatings from polymer dispersions such aspolyurethane dispersions (BAYHDROL®, etc.), fibrin, collagen andderivatives thereof, polysaccharides such as celluloses, starches,dextrans, alginates and derivatives, hyaluronic acid, squaleneemulsions, polyacrylic acid, available, for example, as HYDROPLUS®(Boston Scientific Corporation, Natick, Mass.), and described in U.S.Pat. No. 5,091,205, the disclosure of which is hereby incorporatedherein by reference. Desirably, the coating may be a copolymer ofpolylactic acid and polycaprolactone.

Non-genetic therapeutic agents include anti-thrombogenic agents such asheparin, heparin derivatives, urokinase, and PPack (dextrophenylalanineproline arginine chloromethylketone); anti-proliferative agents such asenoxaprin, angiopeptin, or monoclonal antibodies capable of blockingsmooth muscle cell proliferation, hirudin, and acetylsalicylic acid;anti-inflammatory agents such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine;antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel,5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones,endostatin, angiostatin and thymidine kinase inhibitors; anestheticagents such as lidocaine, bupivacaine, and ropivacaine; anti-coagulantssuch as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containingcompound, heparin, antithrombin compounds, platelet receptorantagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors andtick antiplatelet peptides; vascular cell growth promoters such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters; vascular cellgrowth inhibitors such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin; cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

Genetic materials include anti-sense DNA and RNA, DNA coding foranti-sense RNA, tRNA or rRNA to replace defective or deficientendogenous molecules, angiogenic factors including growth factors suchas acidic and basic fibroblast growth factors, vascular endothelialgrowth factor, epidermal growth factor, transforming growth factor α andβ, platelet-derived endothelial growth factor, platelet-derived growthfactor, tumor necrosis factor α, hepatocyte growth factor and insulinlike growth factor, cell cycle inhibitors including CD inhibitors,thymidine kinase (“TK”) and other agents useful for interfering withcell proliferation, the family of bone morphogenic proteins (“BMP's”),BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9,BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, and BMP 16. Dimericproteins such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7 can beprovided as homodimers, heterodimers, or combinations thereof, alone ortogether with other molecules. Alternatively or, in addition, moleculescapable of inducing an upstream or downstream effect of a BMP can beprovided. Such molecules include any of the “hedgehog” proteins, or theDNA's encoding them.

Cells can be of human origin (autologous or allogeneic) or from ananimal source (xenogeneic), or genetically engineered if desired todeliver proteins of interest at the transplant site. The delivery mediacan be formulated as needed to maintain cell function and viability.

Other suitable therapeutic agents include antibiotics and radioactivecoatings.

The invention is also directed to an apparatus for configuring a medicalballoon of a medical balloon catheter assembly. The apparatus comprisesa catheter holder, a plurality of movable blades disposed about a commoncentral point and one or more blade moving devices in mechanicalcommunication with the movable blades, the one or more blade movingdevices is capable of moving the movable blades inward toward the commoncentral point.

An example of an inventive balloon configuring apparatus is shownschematically at 200 in FIGS. 21-24. Apparatus 200 comprises a catheterholder 204, at least one and desirably a plurality of impinging members114 and a means for moving the impinging members.

As shown by way of example in FIG. 21, the means for moving theimpinging members, as shown in FIG. 24 is in the form of a circularplate 213 with a plurality of openings 215 therethrough. Openings 215are arcuate and angle radially inward. Each impinging member 114 extendsfrom an arm 217 which, in turn, has a circular knob 219 extendingtherefrom as shown in FIG. 24. Each knob 219 is disposed in an opening215. The knob and opening are sized such that the knob engages the innerwalls of the opening.

Circular plate 213 is rotatably associated with support 221 via a camshaft (not shown) using any means known in the art. Circular plate 213may be rotated using any means known in the art. One example is a linearactuator device or a piston system for driving a cam. Shown in thisembodiment is a linear actuator mount 225 is fixedly attached to support221 and includes a coupling 227 for a linear actuator (not shown) fordriving the cam which in turn rotates the circular plate 213. A bearinghousing 223 is mounted on support 221 whereby the cam shaft is adaptedto rotate relative to the bearing housing 223. As the linear actuator isdriven forward or backward, the cam shaft rotates causing the circularplate 213 to rotate in a first direction or in a second, oppositedirection causing arms 217 and impinging members 114 to move radiallyinward or outward depending on the direction of rotation of the circularplate.

Such assemblies for moving the impinging members is described above byway of example only and are well known to those of skill in the art. Anyother suitable device for moving the impinging members may also be usedincluding a piston system.

Impinging members 114, as shown in greater detail in FIG. 25 and FIG.26, are in the form of a tensioned line 210 which is held by line holder212 which extend from body 216. Typically, the tension of the line maybe adjusted by turning knob 214 clockwise or clockwise to increase ordecrease the tension of the member. Desirably, the line is provided inthe form of a smooth metal wire to avoid damaging the balloon. Othersuitable materials include polymeric cables. By way of non-limitingexample, a polyamide based cable may be used. The embodiment of theimpinging member of FIG. 26 differs from the embodiment of FIG. 25 inthat line 210 as shown in FIG. 26 is supported only at a single end. Inthe embodiment of FIG. 26, the line will typically be in the form of arigid polymeric material.

Impinging members 114 are shown in an arrangement along with impingingmembers 108 in perspective view and in side view in FIGS. 27 and 28.Impinging members 108 have a relatively wide balloon contacting surfaceas compared with impinging members 114. Any suitable material may beused for impinging members 108 including polymeric materials and metals.The balloon contacting surface of the impinging member should be smoothto avoid damaging the balloon.

The impinging members 108 and 114 of device 200 operate in unison.Inventive balloon configuring devices may also be provided in whichimpinging members 108 are controlled independently of impinging members114. This may be accomplished by driving each of the impinging membersshown in FIGS. 27 and 28 with a piston (not shown). The pistons drivingimpinging members 108 would be controlled independently of the pistonsdriving impinging members 114. A balloon configuring device may also beprovided where each of the impinging members is independently movable,such as with independently controlled pistons. The device may also beconfigured so that each of the pistons may be slidable along a track.FIG. 29 is a schematic illustration showing impinging member 114 mountedon track 231 allowing for the impinging member to be withdrawn not onlyin a radial direction but also in an axially direction.

In one aspect, a method of configuring a medical balloon catheterassembly is provided. The method comprises the steps of: providing amedical balloon catheter assembly including a medical balloon; at leastpartially inflating the medical balloon; forming a plurality of primarylobes in the balloon, the primary lobes spaced about the periphery ofthe balloon and extending from a central portion of the balloon;manipulating at least one primary lobe to form at least two secondarylobes therefrom; and deflating the balloon. In at least one embodiment,all of the primary lobes are manipulated so as to form at least twoadjacent secondary lobes from each primary lobe. In at least oneembodiment, a radially inward force is applied to each primary lobeduring the manipulating step to form a pair of secondary lobes from eachprimary lobe.

In at least one embodiment, the method further comprises the step ofapplying a vacuum to the balloon during the deflating step.

In at least one embodiment, the method further comprises the step ofproviding a plurality of first impinging members spaced about theperiphery of the balloon, wherein the primary lobes are formed bydirecting the plurality of first impinging members radially inward toapply a radially inward force to the balloon at a plurality oflocations.

In at least one embodiment, the method further comprises the step ofproviding a plurality of second impinging members spaced about theperiphery of the balloon, wherein the secondary lobes are formed bydirecting the plurality of second impinging members radially inward tothe primary lobes to apply a radially inward force to the primary lobes.

In at least one embodiment, the method further comprises the step ofwrapping the deflated secondary lobes about the central portion of theballoon. In at least one embodiment, the secondary lobes are formed fromthe same primary lobe, and the secondary lobes are wrapped in oppositedirections from one another about the central portion of the balloon. Inat least one embodiment, the first impinging members continue to contactthe balloon while the second impinging members are directed radiallyinward to the primary lobes to form the secondary lobes. In at least oneembodiment, the first impinging members are removed from contact withthe balloon prior to wrapping the secondary lobes. In at least oneembodiment, the wrapping step includes the steps of: wrapping everyother secondary lobe in a first direction about the central portion ofthe balloon and subsequently wrapping any unwrapped lobes in a seconddirection opposite the first direction about the central portion of theballoon.

In at least one embodiment, each pair of secondary lobes includes afirst secondary lobe which overlaps one secondary lobe from an adjacentpair of secondary lobes and a second secondary lobe which is overlappedby one secondary lobe from another adjacent pair of secondary lobes.

In at least one embodiment, a plurality of third impinging members areprovided and every other secondary lobe is wrapped by applying thereto aforce directed toward the central portion of the balloon with a thirdimpinging member. In at least one embodiment, a plurality fourthimpinging members are provided and every remaining unwrapped lobe issubsequently wrapped by applying thereto a force directed toward thecentral portion of the balloon with a fourth impinging member.

In at least one embodiment, at least one of the primary lobes ismanipulated to form at least three secondary lobes. In one embodiment,each primary lobe is manipulated to form at least three secondary lobestherefrom. In one embodiment, the primary lobes are formed by impingingone or more first impinging members inward against the balloon and thesecondary lobes are formed by impinging two or more second impingingmembers inward against each primary lobe. In one embodiment, a firstsecondary lobe, a second secondary lobe and a third secondary lobe areformed from each primary lobe, the first secondary lobe larger than thesecond secondary lobe and the third secondary lobe.

In at least one embodiment, a vacuum is applied to the balloon duringthe deflating step to form a plurality of antenna-shaped structuresextending from a central portion of the balloon, each antenna-shapedstructure including a center antenna portion extending outward from theballoon and a plurality of wings extending from a first side of thecenter antenna portion and a plurality of wings extending from a secondside of the center antenna portion opposite the first side. In at leastone embodiment, the antenna-shaped structure includes two wingsextending from the first side of the central portion of the balloon andtwo wings extending from the second side of the central portion of theballoon.

In another aspect, a medical balloon has a central portion and aplurality of wings disposed thereabout. The plurality of wings includeat least one first wing wrapped in a first direction about the centralportion of the balloon and at least one second wing wrapped in a seconddirection opposite the first direction about the central portion of theballoon. In one embodiment, a plurality of first wings are wrapped inthe first direction about the central portion of the balloon and aplurality of second wings are wrapped in the second direction about thecentral portion of the balloon. In one embodiment, the first and secondwings alternate with one another about the central portion of theballoon. In one embodiment, the balloon further comprises a plurality ofT-shaped structures extending from the central portion of the balloon,each T-shaped structure including one first wing and one second wing. Inone embodiment, each secondary wing is in an overlapping relationshipwith one first wing. In at least one embodiment, the balloon comprises aplurality of pairs of first and second wings, each pair of first andsecond wings comprising first wing and the second wing nearest thereto,the pairs spaced about the central portion of the balloon. In at leastone embodiment, a stent is disposed about the medical balloon. In oneembodiment, the stent comprises a therapeutic agent.

In another aspect, a medical balloon has a central portion and aplurality of structures extending from the central portion, thestructures each comprising a first wing extending therefrom in a firstdirection and a second wing extending therefrom in a second directionopposite the first direction. In one embodiment, the structures areT-shaped or V-shaped. In at least one embodiment, a stent is disposedabout the medical balloon. In one embodiment, the stent comprises atherapeutic agent.

In another aspect, a method of forming balloon wings in a medicalballoon is provided. The method comprises the steps of: providing amedical balloon with one or more primary lobes therein; forming aplurality of secondary lobes from each primary lobe by applying aninward force to each of the primary lobes; and deflating the balloon. Inone embodiment, the inward force is applied to the primary lobes via aplurality of impinging members. In one embodiment, the impinging membersare removed following the forming step by moving the impinging membersin an axial direction.

In another aspect, a medical balloon is provided and an expandableprosthetic device disposed about the medical balloon. The medicalballoon comprises a plurality of wings extending from a main balloonbody, the wings wrapped about the main balloon body such that uponinflation of the medical balloon there is substantially no relativerotational movement between the prosthetic device and the balloon.

In another aspect, an apparatus for configuring a medical balloon of amedical balloon catheter assembly is provided. The apparatus comprises acatheter holder, a plurality of movable blades disposed about a commoncentral point and one or more blade moving devices in mechanicalcommunication with the movable blades, the one or more blade movingdevices capable of moving the movable blades inward toward the commoncentral point. In at least one embodiment, the apparatus comprises asingle blade moving device.

The above disclosure is intended to be illustrative and not exhaustive.This description will suggest many variations and alternatives to one ofordinary skill in this art. All these alternatives and variations areintended to be included within the scope of the claims where the term“comprising” means “including, but not limited to”. Those familiar withthe art may recognize other equivalents to the specific embodimentsdescribed herein which equivalents are also intended to be encompassedby the claims.

Further, the particular features presented in the dependent claims canbe combined with each other in other manners within the scope of theinvention such that the invention should be recognized as alsospecifically directed to other embodiments having any other possiblecombination of the features of the dependent claims. For instance, forpurposes of claim publication, any dependent claim which follows shouldbe taken as alternatively written in a multiple dependent form from allprior claims which possess all antecedents referenced in such dependentclaim if such multiple dependent format is an accepted format within thejurisdiction (e.g. each claim depending directly from claim 1 should bealternatively taken as depending from all previous claims). Injurisdictions where multiple dependent claim formats are restricted, thefollowing dependent claims should each be also taken as alternativelywritten in each singly dependent claim format which creates a dependencyfrom a prior antecedent-possessing claim other than the specific claimlisted in such dependent claim below (e.g. claim 3 may be taken asalternatively dependent from claim 1; claim 4 may be taken asalternatively dependent on claim 2, or on claim 1; claim 5 may be takenas alternatively dependent on claim 1, 2, or 3; etc.).

This completes the description of the preferred and alternateembodiments of the invention. Those skilled in the art may recognizeother equivalents to the specific embodiment described herein whichequivalents are intended to be encompassed by the claims attachedhereto.

1. A method of configuring a medical balloon catheter assemblycomprising the steps of: providing a medical balloon catheter assemblyincluding a medical balloon; at least partially inflating the medicalballoon; forming a plurality of primary lobes in the balloon, theprimary lobes spaced about the periphery of the balloon and extendingfrom a central portion of the balloon; manipulating at least one primarylobe to form at least two secondary lobes therefrom; and deflating theballoon.
 2. The method of claim 1 wherein a radially inward force isapplied to each primary lobe during the manipulating step to form a pairof secondary lobes from each primary lobe.
 3. The method of claim 2further comprising the step of applying a vacuum to the balloon duringthe deflating step.
 4. The method of claim 3 further comprising the stepof providing a plurality of first impinging members spaced about theperiphery of the balloon and wherein the primary lobes are formed bydirecting the plurality of first impinging members radially inward toapply a radially inward force to the balloon at a plurality oflocations.
 5. The method of claim 4 further comprising the step ofproviding a plurality of second impinging members spaced about theperiphery of the balloon and wherein the secondary lobes are formed bydirecting the plurality of second impinging members radially inward tothe primary lobes to apply a radially inward force to the primary lobes.6. The method of claim 5 further comprising the step of wrapping thedeflated secondary lobes about the central portion of the balloon. 7.The method of claim 6 where secondary lobes, which are formed from thesame primary lobe, are wrapped in opposite directions from one anotherabout the central portion of the balloon.
 8. The method of claim 7wherein, the wrapping step includes the steps of: wrapping every othersecondary lobe in a first direction about the central portion of theballoon and subsequently wrapping any unwrapped lobes in a seconddirection opposite the first direction about the central portion of theballoon.
 9. The method of claim 8 wherein each pair of secondary lobesincludes a first secondary lobe which overlaps one secondary lobe froman adjacent pair of secondary lobes and a second secondary lobe which isoverlapped by one secondary lobe from another adjacent pair of secondarylobes.
 10. The method of claim 1 wherein at least one of the primarylobes is manipulated to form at least three secondary lobes.
 11. Themethod of claim 10 wherein each primary lobe is manipulated to form atleast three secondary lobes therefrom.
 12. The method of claim 11wherein the primary lobes are formed by impinging one or more firstimpinging members inward against the balloon and the secondary lobes areformed by impinging two or more second impinging members inward againsteach primary lobe.
 13. The method of claim 12 wherein a first secondarylobe, a second secondary lobe and a third secondary lobe are formed fromeach primary lobe, the first secondary lobe larger than the secondsecondary lobe and the third secondary lobe.
 14. The method of claim 13further wherein during the deflating step, a vacuum is applied to theballoon to form a plurality of antenna-shaped structures extending froma central portion of the balloon, each antenna-shaped structureincluding a center antenna portion extending outward from the balloonand a plurality of wings extending from a first side of the centerantenna portion and a plurality of wings extending from a second side ofthe center antenna portion opposite the first side.
 15. A method offorming balloon wings in a medical balloon comprising the steps of:providing a medical balloon with one or more primary lobes therein;forming a plurality of secondary lobes from each primary lobe byapplying an inward force to each of the primary lobes; and deflating theballoon.
 16. The method of claim 15 wherein the inward force is appliedto the primary lobes via a plurality of impinging members.
 17. Themethod of claim 16 wherein the impinging members are removed followingthe forming step by moving the impinging members in an axial direction.18. A medical balloon having a central portion and a plurality ofstructures disposed thereabout, each structure including a first portionextending outward from the balloon and a plurality of wings extendingfrom a first side of the first portion and a plurality of wingsextending from a second side of the first portion opposite the firstside.
 19. The medical balloon of claim 18, wherein the plurality ofwings extending from the first side of the first portion comprises atleast a first wing and a second wing, wherein when the balloon is in adeflated configuration, the first wing overlaps the second wing.
 20. Themedical balloon of claim 18, wherein the plurality of wings extendingfrom the second side of the first portion comprises at least a firstwing and a second wing, wherein when the balloon is in a deflatedconfiguration, the first wing overlaps the second wing.